Janssen Seeks European Approval of Extended Indication for Rybrevant

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The Janssen Pharmaceutical Companies of Johnson & Johnson have requested an extension to the indication application of its fully-human, bispecific antibody treatment, Rybrevant (amivantamab). The submission was announced in an Oct. 6, 2023 company press release.

In the Type II extension request, submitted to the European Medicines Agency (EMA), Janssen is seeking approval for its amivantamab therapy to be used in combination with chemotherapy (carboplatin and pemetrexed) as a first-line treatment for adults with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Janssens’ antibody therapy was granted conditional marketing authorization by the European Commission in December 2021 as a monotherapy for adults with NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy has been unsuccessful.

The indication extension application to EMA is supported by the results of a Phase III clinical study (PAPILLON) that has evaluated the efficacy and safety of amivantamab in combination with chemotherapy as a first line treatment for NSCLC patients with EGFR exon 20 insertion mutations. In July 2023, Janssen revealed that the Phase III study met its primary endpoint, demonstrating that the combination of amivantamab with chemotherapy provided a statistically significant and clinically meaningful improvement in progression-free survival for patients when compared with chemotherapy alone.


“People living with advanced or metastatic NSCLC with activating EGFR exon 20 insertion mutations generally face a poor survival probability, and new treatment options are urgently needed from the very first line of therapy,” said Martin Vogel, EMEA Therapeutic Area Lead Oncology, Janssen-Cilag, in the press release. “Today’s submission to the EMA highlights our deep commitment to change the trajectory of lung cancer, through earlier intervention with targeted treatment options for eligible patients.”

“PAPILLON is the first randomised Phase [III] study to read out in patients with NSCLC with EGFR exon 20 insertion mutations. Pending approval, this creates an opportunity to make a significant improvement to the standard of care for this patient population, where high unmet medical needs remain,” added Kiran Patel, vice president, Clinical Development, Solid Tumors, Janssen Research & Development, in the press release. “We look forward to working with the EMA to bring this potential new indication to the lung cancer community as soon as possible.”

Source: Janssen